Public Bill Committee

[Mr. Roger Gale in the Chair]

(Except clauses 4, 11, 14 and 23, schedule 2, and any new clauses or new schedules relating to the termination of pregnancy by registered medical practitioners) - Written evidence to be reported to the House

HF01 Jane Majkawski

Clause 3

Question proposed [this day], That the clause stand part of the Bill.

Question again proposed.

Dawn Primarolo: Before we broke for lunch, I was responding to the hon. Member for Oxford, West and Abingdon on the subject of artificial gametes. I was explaining to the Committee that there is currently research into in vitro maturation and in vitro growth of gametes, and this involves taking immature eggs or sperm and maturing them in vitro. This could allow eggs to be matured from ovarian tissue and sperm from testicular tissue without the need for the tissue to be transplanted back into someone. It could also be used to treat certain types of infertility where there the development of the eggs or sperm is blocked.
The current definitions do allow gametes matured in vitro to be considered permitted. The Bill also allows research into the development of artificial gametes, including the ultimate test as to whether an artificial gamete is considered functional fertilisation. If an artificially derived sperm can fertilise an egg, or an artificially derived egg can be fertilised, the sperm or the egg could be described as functional. However, the hon. Gentleman, in quoting various references, including quite a lot of the debate in another place, did not do justice to the challenge that researchers face. A lot more research and reassurance would be required on the functionality of such gametes before it would be appropriate to use them in treatment.
The Government’s position is that, if research into artificial gametes demonstrates that they might effectively be used in treatment, this should of course be considered. However, our current view is that there is too little research into how these cells might be derived, and into the safety of such techniques, to be able to make an informed judgment about their use. The application of this technology would be highly significant. It would mean a baby being born having been created from cells other than eggs and sperm, and it is my view that it would not be appropriate to allow such a significant development without proper consultation and parliamentary scrutiny.
The hon. Gentleman touched on that himself when he quoted the British Medical Association. I disagree with the view of the BMA in that I think we need more than regulations—even affirmative ones—in order to discuss the matter. It is something that will significantly change the way people have children, and it is entirely appropriate that proper consideration is given to any decision about allowing it. The hon. Gentleman also touched on who, under the regulations, would be allowed such treatment, and whether the regulations could prescribe those who would be allowed access to this treatment if it turned out, in x years’ time, to be successful. Given all the complexities with regard to DNA and its development, and this particular route of research, could any regulations restrict those who would be entitled to apply for it?
First, any regulating power would need to be considered in the light of the need for the Government’s action to be compatible with the European convention on human rights. If the technology could be made available to same-sex couples and heterosexual couples—and there is a continual series of “if”s in these sentences—there would need to be a strong, objective justification for treating same-sex couples differently. I have to say to the hon. Gentleman, regardless of whom he has spoken to in his extensive discussions on this matter, that I am not aware of any such strong justification for the writing of a power to prevent access by some.
Of course, the point about discrimination is crucial. The use of this technology for heterosexual couples only would be difficult to justify objectively, but there are wider questions. This is fundamentally different. It raises different ethical issues to those raised on mitochondrial donation. The Government are not saying “no” to this ever happening in the future. We are saying that, at the point at which this research is, further work needs to be done, further consideration of the ethical and scientific reasons for pursuing it—

Evan Harris: Will the right hon. Lady give way?

Dawn Primarolo: The hon. Gentleman spoke for half an hour. If he will allow me to conclude my points, I will be happy for him to come back in.
It also seems to me that when this House considers the science, particularly in this area, we need to be able to satisfy ourselves where that science may take us, what issues will be raised and whether or not we feel able to come to decisions on this subject. His hon. Friend the Member for Southport talked about a blank cheque. I entirely reject that notion. Research is at an early stage, and we are not clear where it is taking us. We have not had a full debate about what is possible or discussion of the ethical issues involved. The Government are not saying no to the idea, but we are saying that further consideration needs to be given and proper consultation carried out. Now is not the time, and a regulating power is not the way forward.
That is why, when the hon. Member for Oxford, West and Abingdon and others raised it before, the Government declined to take the route that they suggested. It is not the right way to proceed with legislation to say afterwards that we will answer all the questions once we have given a regulating power that we may or may not switch on. In the previous discussions, we clearly flagged up what the regulations would need to address—for instance, for mitochondrial donation, and those debates are already going on. It is on that basis that I would decline such an amendment to the Bill if it were before us—it is not. I hope that the clause will stand part of the Bill.

Evan Harris: It is not clear to me whether the Minister is giving way. If she does not give way, her remarks become just an exposition. The whole point of a ministerial response to a debate is to allow interventions if the Minister is sure of her ground, as I am sure the right hon. Lady is. I do not know why she would not wish to take interventions. If she does not, it gives her the right to stay seated and not respond to specific questions after she has set out her position. So I am asking whether she is willing to respond again—
Dawn Primaroloindicated dissent.

Roger Gale: Order. The right hon. Lady has made her position plain. She has stated her case and she has sat down. It is entirely open to the hon. Gentleman to come back, as the right hon. Lady indicated.

Evan Harris: I am coming back, but I was wondering whether I would be wasting my breath in a sense in asking her to respond to particular points, as is usual in a Committee stage debate, or whether she is just intending to stay seated. I would like to know that so that I can bear it in mind when I choose what points to make. Either I am making concluding points, or I am asking further questions.

Roger Gale: Order. I suggest, respectfully, that the hon. Gentleman puts it to the test.

Evan Harris: I think that is wise advice. Let us see if the Minister is prepared to answer a couple of questions. I am grateful to her for setting out what she did, and I would like to deal with two key points that she raised. First, on discrimination. she argued that strong, objective justification would be needed to treat same-sex couples differently from heterosexual couples. This is an interesting question, because we are talking about whether an individual will be able to access specific treatment. An infertile male who is being treated with a woman may currently receive treatment from an in vitro fertilisation clinic in the form, for example, of donor sperm—they do not receive donor eggs. Where a woman is infertile, the problem is dealt with by means of donor eggs, not donor sperm. That could be an individual woman seeking treatment on her own, where no couple is involved.
One could therefore argue that the test is whether the person is being treated in a reasonable way and whether they are receiving treatment. My understanding of the Human Rights Act 1998 is that it does not give people the right to receive a specific treatment, as long as they are not unreasonably, disproportionately discriminated against in accessing treatment or services. My first question, therefore, is whether the Government have legal advice stating that there is an issue of discrimination against same-sex couples. Secondly, can they see no objective justification for legitimising the distinction that I have described by setting it out in regulations that a man must be treated with sperm from stem cells and that a woman must be treated with eggs from stem cells? I have taken informal advice from human rights lawyers, and they believe that there is an objective justification for such a provision, even if it involves different treatment that might be considered indirectly discriminatory. Same-sex couples can be treated with donor sperm and eggs. We are talking about treating infertile individuals to give them their only chance to have children with the same genetic relationship that one would expect with a father.
On my second question, the Minister said that the proposals would raise different ethical issues, and I listened carefully to what she said in identifying them. She said that the proposals would significantly change the way in which people have children and that we would be creating children through cells other than eggs or sperm. However, I do not think that we would be doing that, because we would still have to create an embryo “by...fertilisation”, to use the words in the clause. The fertilisation would have to be done by a germ cell, even if it had been derived from a somatic cell. The words in the clause—I am keen to stick to them—specify that very clearly. It cannot be said that the regulations would allow anything other than an embryo to be created by fertilisation. The Minister herself referred to the fact that gametes are widely defined for these purposes as germline cells at any stage of maturation. They are not necessarily sperm or eggs—they are certainly not necessarily sperm. Immature spermatagonal cells count as gametes in this respect. If they are grown or matured in vitro, they would not necessarily be sperm. The Bill therefore already provides for embryos to be created by fertilisation using cells that are not sperm—we should be clear about that. Given that necessary protection in the Bill, it is not right to say that embryos will be created by cells other than eggs or sperm, except to the extent that is already permitted for immature gametes for the purposes that the Minister has set out.
The proposals would not significantly change the way in which people have children. If the Government thought that the issue was ripe for consultation in 2005—indeed, it was put out for consultation—it should be ripe for discussion in the House now. It cannot be considered premature, a priori, to debate the issue in the House of Lords and the House of Commons. In 2005, the Government were of the view that a regulation-making power was legitimate; that is the position that they started from in their consultation paper. I am concerned that they have decided against allowing a regulation-making power without having very good reasons, albeit that they have pragmatic concerns. Their position is not clear to me. It does not look as though the Minister is responding to the two points that I am making.
In a consensus statement dated 11 April 2008, the Hinxton group set out how close it thought this science was to reaching the clinic. My understanding is that this peer review group thought that it was five to 10 years away. That is before the time scale within which another Bill is likely to be introduced. They recommended that the Government look kindly on permissive legislation which would allow that to happen, and made it clear that they thought there was a great deal of hope, with this technology, for clinical treatment of individuals. It is unfortunate that the Government seem to be opposed to allowing a regulation-making power now without setting out clearly why they think it would be discriminatory to restrict it and, separately, what the key ethical issues are and why they are new compared to other issues.
I conclude my remarks by regretting that the Government have not been willing to set out clearly their grounds for believing that the amendment tabled in the Lords would be too discriminatory, not setting out why they think there are fresh and significant ethical concerns here, and not appearing to be willing to have a debate in a Committee of Parliament about those issues.

Dawn Primarolo: The hon. Gentleman creates a case, advances it, and then, when he does not get the answer he wants, says that a justification has not been given. He asked me a question about discrimination, and I gave him the answer with regard to advice. The hon. Gentleman knows that it is not normal for Governments to publish legal advice, and we are not about to start now. I went on to say that, notwithstanding the advice, there are ethical issues, beyond what is in the Bill, that need further consideration, and there is a difference between what we are currently providing for and what would be provided for in these circumstances. What we have is a stand-off. The hon. Gentleman simply does not agree with me. It seems to me that there is a difference between a power dealing with mitochondrial donation to avoid the transmission of serious diseases and with the repairing of existing embryos—which is where the regulation-making power is—and a different power dealing with artificial gametes and the creation of gametes and new life. There is a fine distinction.
On behalf of the Government, I am saying not that we have set our face against this, but that further discussion and further consideration of the issues is needed. I hear what the hon. Gentleman says, but not everybody agrees about how far away the science is from possible use. The appropriate way forward would be proper consultation on these issues and, if necessary, amendments to primary legislation. That is a far more significant and important place to have these sorts of discussions. I hear what the hon. Gentleman is saying and I understand that he disagrees with me, but no matter how many times he puts this proposition to me, that will be my reply on behalf of the Government. 
There is a question of understanding the very fine differences between what science might be able to do in the future and how we seek to regulate it, and that goes to the very heart of what we are trying to deal with in discussing this Bill and its predecessor. Discrimination is a subset of that, but the ethical issues must come first. I am sorry if the hon. Gentleman does not agree because there is a lot about which we have agreed. However, in response to his raising such important issues in a clause stand part debate, I have laid out the reasons for the Government’s view and if the House takes a different view, that is a matter for the House. We remain wedded to our view.

Question put and agreed to.

Clause 3 ordered to stand part of the Bill.

Clause 5 ordered to stand part of the Bill.

Schedule 1

Amendments to Schedule 1 to the 1990 Act relating to membership of the Authority

Mark Simmonds: I beg to move amendment No. 22, in schedule 1, page 54, line 4, at end insert—
‘(za) at end of sub-paragraph (2) insert—
“and no person may be appointed for more than six years in total”.’.
May I take amendment No. 23 with amendment No. 22?

Roger Gale: Order. I have no strong aversion to that, but we separated the amendments deliberately because they do not cover the same issues. The hon. Gentleman will have the opportunity to debate both amendments, but preferably one at a time.

Mark Simmonds: Thank you for your guidance, Mr. Gale. The purpose of amendment No. 22 is to get across to both the Government and the Human Fertilisation and Embryology Authority that, while the HFEA is held in very high regard and is perceived globally as the lead regulator in such issues, there is concern that it has in the past and perhaps will in the future be a closed shop. The amendment would ensure that amenable clinicians who wished to serve on the HFEA and others who wanted to be reappointed could not be reappointed again and again, as can happen at the moment. The effect of that practice is keeping others out as the ratio of expert members is limited.
The majority of clinics have a good relationship with the HFEA, but that is not universal, as I have found out in my meetings with those who have had dealings with the HFEA. Some clinics have had difficulties and they put that down primarily—not solely—to the static membership of the authority. There have also been issues of competitive conflict, and it is important that clinicians do not sit on licensing committees when determining policy that might have a beneficial impact on their own clinics. I shall not give specific examples of that, but I am sure that officials are aware that that has happened.
Under the amendment, members of the HFEA could not stand for more than two consecutive terms.

Evan Harris: Does the hon. Gentleman have similar concerns about clinicians who are rivals to other clinicians being involved in inspections, and delivering a report that might impact on the business of those other people? I do not know whether it is possible to avoid that situation, but perhaps it also needs to be considered.

Mark Simmonds: The hon. Gentleman is absolutely right. The purpose of a future amendment is not only to ensure that such a situation does not arise, but to prevent clinicians without specialist and expert knowledge in certain subjects producing reports that often have to be corrected or reworked later. I shall deal with that when we come to the subsequent amendment.
It would also be helpful if the HFEA made public the dates of appointments so that people could see how long someone had been a member of the authority. The public should also be given assurances about the HFEA’s fresh expertise and vigour. It is clear from my discussions that if the Bill passes—as most of us on this Committee hope it will, as a result of the substantial discussions in pre-legislative scrutiny and both Houses of Parliament—the HFEA will have an even busier time, as we gradually extend the type of activities that it can license. It is therefore important that it does not atrophy—although I am not suggesting that it has—but continues to move forward with vigour, bringing in new blood as often as possible. That is the purpose of amendment No. 22.

Dawn Primarolo: Members of the HFEA are appointed by the Appointments Commission on behalf of the Secretary of State for Health following advertisements in the national press. Anyone is free to apply and can be considered for membership. The Human Fertilisation and Embryology Act 1990 provides that:
“A person shall not be appointed as a member of the Authority for more than three years at a time”.
However, that can be extended for another three years with the agreement of the Appointments Commission. After six years, if members wish to continue to sit on the authority, it is not prohibited, but they must reapply through an open competition. They may be reappointed, but only if they are the best candidate for the job.
The hon. Gentleman’s amendment would set a six-year limit on the full period that any member can serve. Although it does not necessarily sound unreasonable, it would mean a lack of flexibility to reappoint people with valuable expertise and experience in their field. It is essential that the HFEA comprises the best calibre of candidates available. The amendment could restrict that.
While the hon. Gentleman was speaking, I was looking at some of my notes in relation to his point about the dates when people were appointed and how long their term ran for. I do not have that information. I think that some members of the HFEA have served for more than six years, but they started before the process was run by the Appointments Commission. I understand that three members have served for six years. They would have to apply for reappointment under the current recruitment exercise.

Michael Penning: Will the Minister clarify whether that is retrospective? If they have already served six years when the legislation comes into force, will they then have another three plus three before they have to apply, or will the previous years be taken into account, meaning that they will have to apply straight away?

Dawn Primarolo: I think that I am correct in saying that, once the Appointments Commission became responsible, the period considered included whatever period they might already have served. If the hon. Gentleman will forgive me, I will need to double-check that, but the point is that it is common on many public bodies to have a period in which people can be reappointed before going through a complete re-application. As I said to the hon. Member for Boston and Skegness, an open competition is advertised and run by the Appointments Commission, which is specifically charged with ensuring that the public body—in this case HFEA—is staffed by people with appropriate skills. It will also look to ensure that anybody who applies meets the specification. Although this is published nationally, that would still happen. I am not aware whether appointment periods are in the public domain or whether they were on the HFEA website. I do not have that information to hand, but I am happy to check.
What the hon. Gentleman is trying to achieve in terms of the make up of the HFEA is already in place with respect to the break at six years and the need to reapply. I am sure that he would agree that the converse is true, and that even if someone has served six years, if they clearly have the expertise and are the best person despite advertising, national recruitment and consideration, we would not want to refuse them access to being appointed by the Appointments Commission. I hope that he is reassured that he can track how long members have served—I will check that that is the case—and that there is, in effect, a six-year break, with the caveat that people can reapply. I am sure that he would agree with that, and I hope that he is satisfied.

Mark Simmonds: I am grateful to the Minister for that response. Of course, I understand and agree with the flexibility argument that she put forward. Obviously, we must have people of the best calibre on the authority. However, she will also be aware that there are a limited number of clinician places on the authority. I am not going to press the amendment to a Division, but I wanted to ensure that the Minister, the Committee and those responsible for the HFEA understood the concern that a position on the authority should not be a permanent fixture that is renewable every three years. Certainly, publicly detailing appointment dates and the length of time that those on the authority have served would go some way towards satisfying people, and it would show that there was change and turnover. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Mark Simmonds: I beg to move amendment No. 23, in schedule 1, page 54, line 17, at end add—
‘4 In sub-paragraph 8(2), after “experience”, insert “in at least one of the activities that may be licensed under this Act”.
The amendment would add a provision to schedule 1, which amends the 1990 Act. To return to the point made by the hon. Member for Oxford, West and Abingdon, it would ensure that HFEA inspectors were doctors, embryologists or researchers who were qualified to conduct inspection at IVF research units. That is not necessarily what happens at the moment, and there have been conflicts between clinics and the HFEA, some of which have been successfully challenged through negotiations and, ultimately, the threat of legal action.
The inspection reports take place during the licensed period—either three or five years—or at the end of those licensed periods for renewal for IVF clinics. They are undertaken to inform the authority about whether a licence should be renewed or whether there are issues as the licensed period progresses. Those are, of course, made public and are accessible to those who use the clinics. There have been some issues when the interim report that the inspectors put together has been completely disagreed with by the clinic. There is a great nervousness among those who run some—although not all—of the clinics that part of the reason for that is that those doing the inspections do not necessarily have the expertise that they require and there is a lack of understanding. There are numerous examples of having to rework the reports.
I understand the positive move that clinics now have the ability to make official responses to those inspectorate reports, which are also made public. However, the starting point must be that those doing the inspections in the first place have a detailed understanding and knowledge of what they are inspecting. Picking up the point made by the hon. Member for Oxford, West and Abingdon, we must also ensure that we do not get into a situation in which someone who is doing an inspection has a conflict of interest, or an interest in producing a relatively negative report on a particular clinic that might may have an advantageous effect on the clinic that they work for.

Evan Harris: I am grateful to the hon. Member for Boston and Skegness for raising this matter. Although I encouraged him to make his point, there is a difficulty for the HFEA in finding someone with clinical expertise who is not in competition with someone else, unless it has a cadre of professional inspectors, which might be possible, or one has a way of identifying people who clearly are not in competition. For example, we would have to consider the situation for people working in London.

Mark Simmonds: The hon. Gentleman is absolutely right to make that point. I am not going to raise specific examples, but I am sure that he will be aware of one particular example in the HFEA when this very situation arose because of the very close proximity in geographical terms of the two clinics. That is the sort of issue that needs to be avoided.

Evan Harris: Absolutely. The hon. Gentleman’s analysis is spot on. I would say that more creative thinking needs to be done by the HFEA to ensure not only that conflicts of interest do not arise, but that suspicions of conflicts of interest do not arise. This is unfortunately—or, some would say, fortunately—a very competitive field in which large amounts of income are at stake. I know that the HFEA and indeed the Government are aware of the situation, which is why they strive to ensure that there are basic standards so that people are not misinformed about what success rates are, for example.

Dawn Primarolo: The hon. Members for Boston and Skegness and for Oxford, West and Abingdon have raised an important point, and the hon. Member for Oxford, West and Abingdon went on to elaborate why the balance is difficult to strike. Perhaps it would be helpful if I gave the hon. Gentlemen some indication of how the HFEA is proceeding.
At present, the HFEA has nine inspectors. Three are embryologists, three are nurses, one is a doctor, one is a scientist and one is a generalist with an audit background. The HFEA has in-house inspectors and no longer uses inspectors from outside the HFEA.
The amendment would require inspectors to have experience in at least one of the activities that may be licensed under the Act. That would mean that the HFEA would be able to recruit only people who were, for example, doctors or nurses with experience in infertility, embryologists, scientists with experience of using human embryos in research, and people who perhaps run internet sperm delivery services—I think that the hon. Member for Oxford, West and Abingdon was touching on that point.
The qualities that make a good inspector are not necessarily limited to experience in licensable activities, although that may be helpful. The ability to gather evidence to ensure that centres are conducting licensable activities in adherence with the Act, the licence conditions, and the code of practice are vital. Therefore, people with experience of auditing or investigating, or scientists, nurses, and doctors with other specialist knowledge, could make equally good inspectors as those who work in the field.
I do recognise, and of course it is obvious, that an understanding of the licensable activities is essential for an HFEA inspector. The authority has thus introduced a competency-based training programme for all new inspectors to achieve that. Part of the programme includes spending time in a licensed centre to observe practice and to gain an understanding of how a centre works from day to day. The HFEA also has a number of external advisors who have experience in activities that may be licensed under the Act, such as nurses, doctors and embryologists who act as inspectors on a number of inspections every year.
I think that the concerns of the hon. Member for Boston and Skegness are being addressed by ensuring that the inspectors are suitably qualified and able to report with regard to the codeand the licence conditions. He and the hon. Member for Oxford, West and Abingdon flag up a live issue to the HFEA concerning a reasonably small community of practitioners, the importance of having such expertise, and the need not to undermine the commercial or business concerns that often underpin these clinics.
I hope that the hon. Member for Boston and Skegness will accept that the amendment is not necessary, that it would be over-restrictive, and that there might be problems with recruiting the qualified people he feels might be necessary. Nonetheless, the HFEA is addressing this matter, and what is important is that the inspectors can consider the issues before them. I hope, on that basis, that he will be prepared to withdraw his amendment.
I am not sure how this might be achieved, but if the hon. Gentleman is particularly interested in the specific work that the HFEA is doing with regard to its in-house inspectors and their qualifications and how to avoid any of the problems that he feels might exist, I am sure that we could find a way of ensuring that he is kept in touch with developments so that he can satisfy himself and his colleagues on those issues.

Mark Simmonds: I thank the Minister for that answer and for the offer to keep me in touch as the HFEA develops its thinking and makes progress in that area. I would certainly like to take her up on that offer. I am pleased that the HFEA recognises that there is an issue that needs to be addressed, and I was comforted by the fact that the Minister felt progress was being made.
Of course, I understand that the community is small and that no particular clinic likes to be criticised, whether that criticism is justified or not. There are clearly sensitivities. Certainly, one of the things I felt when meeting people involved in the clinics was that they tended to divide into two camps: those who were satisfied with the reports and inspections they were getting from the HFEA, and those who definitely were not. This is not the only reason why they were not satisfied, but clearly progress needs to be made. I also understand that we cannot possibly have a situation where we are over-restrictive on the recruiting pool. We need to have appropriate number of inspectors to make inspections, and particularly to produce the interim reports at the end of a licence. On that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Schedule 1 agreed to.

Clause 6

Additional general functions of Authority

Mark Simmonds: I beg to move amendment No. 4, in clause 6, page 5, line 35, leave out subsection (3).
The amendment relates particularly to the charging of fees specifically to give advice. There is no question that there is a necessity for the HFEA to be allowed to charge for licensing, even though some of the licensing fees, based on the number of people benefiting from and using the clinic, are very substantial indeed, in some cases running into the hundreds of thousands of pounds.
The amendment would remove the right of the authority to charge a fee for advice. Will the Minister explain what that advice might be? What, in fact, might the HFEA want to charge for? Surely advice should be freely available to allow those who are considering applying for a licence to have the best opportunity to submit all the relevant documents in the first place. That should be part of a consultation process free at the point of access with the HFEA.
From my reading of the clause, it would also enable the authority to charge a person considering treatment for providing gametes or embryos. In my view, this should be free, as the current process is costly, traumatic and time-consuming enough. There has to be an assumption that the HFEA will give free advice to clinics to enable them to meet the criteria, to get the licence and to ensure that they are safe. There is concern from within the clinic community that HFEA charges could amount to not insubstantial sums for carrying out roles that the authority should be fulfilling in the first place. I am referring to the additional information that is required for obtaining a licence, for renewing a licence, or for future discussions and advice on interim inspection reports.
Will the Minister clarify what sort of categories of advice the HFEA will be able to charge for? Is it advice about confidentiality, consent or licensing? Might it also be advice to those donating embryos and gametes, because the last thing that we want to do is to deter people from wanting to be donors?

Robert Key: I support the amendment very strongly because it addresses the fundamental issue of whether it is right for some of the services in the national health service to be paid for by the patient. Any licence charge is inevitably passed on to patients—and in different ways. Quite a lot of it comes down in the end to postcoding. I object very strongly to the discrimination against fertility centres in the national health service. They find themselves faced with very high charges, as my hon. Friend the Member for Boston and Skegness said. As far as I can see, this measure is an extension of that, although perhaps the Minister will convince me that it is nothing to do with that, that patients will not suffer or lose a penny, and that the primary care trust will not be able to pass on any of the charges to patients.
My basic point is that there should be no discrimination against fertility treatment. Fertility treatment is not a luxury; it relates to a medical condition. The rich will continue to look after themselves. If we are not careful, we will see the national health service clobbering the poor—it is as stark as that. This is an issue of principle. My hon. Friend is seeking, in a far kinder way than me, to press the Minister to explain the measure, and I support him. I shall take some convincing that the amendment should be withdrawn, and I hope that it is not.

Dawn Primarolo: The intention behind the provision is not to implement the charging to which the hon. Members for Salisbury and for Boston and Skegness have referred. The clause provides for a discretion, not a duty. It is discretionary to charge a fee for advice provided under the clause when the advice requested from people to whom licences apply is greater—let me explain.
The provision is intended to allow the HFEA to recover costs that it has incurred in providing specialist advice. It was considered appropriate to make the power discretionary, which enables the HFEA to consider whether a charge is necessary. It is not about income generation. It is a discretionary levy that will be used only when appropriate, such as if a clinic wants to consider what systems it needs to put in place to comply with a European directive. It will be provided for within the national health service if we are required to move the entire service to comply with a particular European directive, or if a restructuring of the service is necessary. The amount of work generated for the HFEA by such a request could go way beyond the usual requests suggested by the hon. Members for Boston and Skegness and for Salisbury.
If the information provided by the HFEA goes beyond that by helping the structure of the business, it has the option to charge a fee. That power will be used sparingly because such a thing will occur only in rare circumstances, but none the less it will happen. The public purse would otherwise be under pressure and strain because of having to provide advice to private organisations on how to comply with requirements. That does not seem to be the correct way to proceed.
I absolutely understand the point made by the hon. Member for Salisbury. I imagine that he was thinking of clinics asking for information. We are talking specifically about them going beyond that and asking for much more detailed advice about compliance or structure.

Jeremy Wright: Of course we accept the Minister’s reassurances once again, albeit with the caveat that she will not always be the Minister. Will she answer this specific question? If I understand her correctly, she seems to be arguing that in the majority of cases in which information or advice is sought by organisations or individuals, the HFEA would not contemplate charging a fee, but that in exceptional cases, it might. Why does the clause not say that a fee is not to be charged save in exceptional circumstances?

Dawn Primarolo: The power would be a duty if it was required in all circumstances. It is a discretionary power regarding not information, but specific advice. If we intended the HFEA to charge for everything—information and advice—we would put a duty on it to do so. We are requiring it to charge, with discretion, if the demand goes beyond information. The authority will have to decide whether to make a charge.

Robert Key: The Minister has the enormous advantage of having been a Treasury Minister for many successful years. She will know that in the arguments that we had with the HFEA over the charging of primary care trusts or, more usually and more directly, fertility clinics, the authority said that it was bound by the instructions of the Treasury. That is about as discretionary as a local council charging council tax to its residents.
I am totally unconvinced by the Minister’s argument. She has been unable to give a guarantee that the charges will be discretionary. We all know of discretionary charges in almost every area of life, and I am not convinced that the charges will not be passed straight on to primary care trusts and fertility clinics—and ultimately to those seeking help.

Dawn Primarolo: I want to resolve this. I understand the hon. Gentleman’s fears, but this is discretion under specific circumstances. If he has a way forward, I would be happy to take a further intervention. When there is a request for substantial advice from the HFEA that would cause substantial cost and go beyond the information that it normally gives or the work that it would normally do, it has the discretion to decide whether or not it charges a fee. It need not definitely charge a fee, but it may do so, to ensure that the public purse is not unduly called upon. Has the hon. Gentleman a way of having that caveat but not removing the provision completely, which is what the amendment would do? The amendment would completely remove the HFEA’s ability to have the discretion to decide whether it wants to recoup its costs in exceptional circumstances when the cost is great.

Robert Key: Of course, the answer is to include the phrase “exceptional circumstances” somewhere and then to define them. Will the Minister also point to anywhere in the Bill that describes what the normal function of the regulatory authority is?

Dawn Primarolo: Given the advice and the information collected, the work that the HFEA has done predicated on the 1990 Act, and the hon. Gentleman’s expertise in this area, he knows full well that the HFEA will be regularly asked for information. The caveat that I am drawing here is about advice. I am loth to leave the HFEA exposed when there might be substantial claims on its resources through providing advice, but I absolutely agree with the hon. Gentleman that we are not sending a signal in the Bill or from the Committee that we would expect everything to be charged. This is a caveat that is additional to the provisions in place. Given that the Bill amends the 1990 Act, when it is silent, it means that the measure is in the 1990 Act.
I want to be open with the Committee, but I do not want to accept a complete removal of the proposition. I would ask the hon. Member for Boston and Skegness to reconsider his amendment and give us time to think about it. Regrettably, if he feels that he must press the amendment to a Division, I fear that I must ask my colleagues to resist it. It would be better to try and sort this out properly.

Mark Simmonds: I listened with great interest to the Minister’s response. She initiated her comments by using the word “discretion”. My hon. Friend the Member for Salisbury ably made the point that Governments have the discretion to raise taxes all the time. I am not suggesting that fees for advice from the HFEA are the equivalent of tax, but they could definitely have an impact on costs for someone wishing to receive treatment from one of the clinics, if an element of those fees was passed on.
If all this is about implementing EU directives, my hon. Friend the Member for Rugby and Kenilworth came up with exactly the right wording: “exceptional circumstances”. I would argue that implementing EU directives is probably an appropriate call on the taxpayer, rather than the individuals using clinics. The HFEA, since its inception, has survived perfectly adequately without having to charge for advice under existing structures. Also, there could be a major deterrent for those who are using the clinics in what is already sometimes an extremely costly exercise.
I am sorry to disappoint the Minister. I am grateful for her offer of looking at the point again, but I am not prepared to withdraw the amendment and I shall press it to a Division.

Question put, That the amendment be made:—

The Committee divided: Ayes 7, Noes 8.

Question accordingly negatived.

Clause 6 ordered to stand part of the Bill.

Clause 7

Duties in relation to carrying out its functions

Question proposed,That the clause stand part of the Bill.

Mark Simmonds: Clause 7 strikes me as a curious measure. It states that the authority, meaning the HFEA, should carry out its duties
“effectively, efficiently and economically”,
but one would have thought that that is implicit for any Government authority. Does it mean that the HFEA has so far been ineffective, inefficient and uneconomic? What would be the impact on the HFEA if the clause was not included? The HFEA’s behaviour and performance should not be altered because it should operate that way whether or not the clause is included.

John Pugh: My question is on proposed new section 8ZA(2), which states:
“In carrying out its functions, the Authority must, so far as is relevant”—
I am not clear when it would not be relevant—
“have regard to the principles of best regulatory practice...including the principles under which regulatory activities should be transparent, accountable”
and so on. It is accepted that the HFEA and its delegated committees will make some big decisions, but it is not guaranteed to be without conflicts of interest, whether financial, as have been mentioned, or based on research—people may wish to encourage research in which they are involved or actively discourage research in which they are involved. In fact, such conflicts of interest, far from being hypothetical, are regarded as extremely likely by most members of the Committee who have spoken. There are also public funding issues.
I recognise that the HFEA has a strong lay element, but in any environment in which there are lay and professional people, the latter have a big impact on what the former decide and think. The HFEA has a strong ethics committee, but that is largely concerned with the treatment of its clients.
It is perfectly likely—I am assured that this happens—that when making decisions that have financial or research implications, members declare and state their interests. However, I pondered some time ago whether there was a standing register of interests. My hon. Friend the Member for Oxford, West and Abingdon declared an interest at the beginning of the previous sitting, but I assume that if we check carefully, we will find a further declaration in the Register of Members’ Interests—[Interruption.] One would indeed hope so. I have scoured HFEA’s website to find out what are people’s relevant standing interests, whether financial or research. I could not find that information, so I contacted the HFEA and asked whether it had a standing register of interests. I thought that that was a good idea if only because there will be huge sums of money riding on some of its decisions—one has only to see the investment by the Wellcome Trust and others to realise how big those sums might be. Does the Minister know whether there is a standing register of interests for HFEA members? If not, suggesting that it produce one might be a laudable way of future-proofing legislation.

Evan Harris: I point out to my hon. Friend that there is a difference between declarable interests that one might want to make Parliament aware of and registerable interests. The registrar is quite fussy about what he or she thinks it is necessary to register.
My point concerns the issue of HFEA mission creep. If the Minister will permit me, I think that it is appropriate to raise it here, because it is relevant to proposed new section 8ZA(2), which says:
“In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).”
It is a minor concern, but I hope that the Minister can set my mind at rest. A couple of years ago, the HFEA sent out a mission statement to Members of Parliament. The mission statement did not stick to what Parliament had intended the HFEA to do. The HFEA decided that part of its job was to maintain public confidence in the law. If Parliament makes the law, it is Parliament’s job to maintain confidence in the law. Otherwise, acceptable activity that Parliament has said should be licensed and considered appropriately should not be subject to extra regulation because of a perceived need to keep public opinion on board.
Otherwise, newspapers could raise scare stories and, if the HFEA’s mission has crept to include a general issue of public confidence rather than what is set out in proposed new section 8ZA(2), it might say, “Well, we might have licensed this and permitted it, but it might kick up a fuss. There’s an institutional risk.” That is the other thing. The HFEA’s policy documents include a little section saying what the risk is to itself of bad headlines, rating them low, medium, high or whatever. It is inappropriate for the HFEA, which was set up by Parliament to do a job—a job that, generally speaking, it does well—to start having regard to interests such as what the Daily Mail might say about its decisions.
The HFEA rowed back from that position when I raised the matter, asking where it came from, as I could not find it in the HFEA’s own terms of reference or the statute. It would be helpful if the Minister confirmed that the excellent paragraph that she proposes to insert in the Bill makes it clear that
“activities should be...targeted only at cases in which action is needed”,
and that nothing in the statute requires the HFEA to distort what it is doing in order to please what it perceives as public or media opinion. Unfortunately, it is in the firing line. I respect the HFEA for what it does, because it gets a lot of hassle from some in the media, and indeed some politicians, when it takes a decision that they do not like. However, it would be open to greater criticism if it bent towards that or away from implied criticism. I hope that she will make it clear, albeit only briefly, that the HFEA’s job is to implement the law as Parliament has laid it down and develop policy where appropriate. Perceptions of public opinion, short of formal consultations where the HFEA feels them to be relevant, are not part of its remit.

Dawn Primarolo: It is always surprising what things catch a Minister in Committee. I thought that clause 7 was very straightforward. Perhaps I can explain why the Government did it and then answer the points.
Of course the Government expect all public authorities to operate effectively, efficiently and economically. That is not a reflection on the HFEA’s past practice or performance. It is simply that the principles of better regulation were implemented following the Hampton report, which was quite a long way after the 1990 Act. They require regulation to be transparent. Regulators should be open and keep regulations simple and user-friendly. Regulation must be accountable. Regulators must be able to justify decisions and be subject to public scrutiny. It must be proportionate. Regulators should intervene only when necessary. Remedies should be appropriate to the risk posed and costs must be identified and minimised. The principles also require regulation to be consistent whereby rules and standards must be joined up and implemented fairly. They require regulation to be targeted so that it is focused on the problem and minimise the side effects.
The Government took the opportunity provided by the fact that we were updating the 1990 Act and included the principles in the Bill. They have been widely accepted by the House. It was no more, no less than that. Such action was not a reflection on the performance of the HFEA. We just took the opportunity offered by the Bill to put on the record something that we already expected. We did so for clarity. We did not mean to cause difficulties in Committee. In answer to the points that have been made, I must say that it is nothing to do with whether I continue to be the Minister; it is simply a tidying-up exercise.
The hon. Member for Southport raised a different issue—a register of what is declared. I am not exactly sure about what detail is provided publicly at the moment, but I agree with him. I shall put to the HFEA the point that such a register should exist and be accessible. It would be good practice and I thank the hon. Gentleman for raising it with me.
The hon. Member for Oxford, West and Abingdon asked me to confirm that the measure is about complying with the Bill, not with the views of the media. I am happy to confirm that. I think that he wanted to make sure that that was on the record, and I am pleased to assist him. I hope that members of the Committee will accept that there was no other motive behind the provision, expect that it is a good principle. I hope that I have put their concerns to rest, and that they agree that what must be the most modest clause in the entire Bill should now stand part.

Question put and agreed to.

Clause 7 ordered to stand part of the Bill.

Clause 8

Power to contract out functions etc.

Question proposed, That the clause stand part of the Bill.

Mark Simmonds: I have one or two queries about the clause. It gives the HFEA the power to contract out particular functions to other Departments or public offices. How would the contracted-out bodies be accountable? It would be helpful if the Minister could give us an idea of which bodies might be involved? Will it be the Human Tissue Authority, the Department of Health or the Medicines and Healthcare products Regulatory Agency? In what circumstances does the Minister think that the powers would be necessary?
To make sure that my understanding of the Bill is correct, I must know whether contracting out will exclude licensing and the guidance of the HFEA, and that there will be no opportunities for licensing, for example. What about inspections? We discussed that earlier. They are not specific to the granting of a licence, but are relevant to it. Such matters go to the authority for discussion and consideration. Will issues be confined to a public authority or will the HFEA contract out to the independent sector, including the private sector? What criteria will be put in place by the Department of Health or will it be left to the HFEA to make sure that the contractee will have the relevant level of appropriate skills and expertise, experience and qualifications to do the particular job?
My third and final specific question about clause 8 concerns proposed new section 8C(2)(c) that states:
“it is a function of making subordinate legislation (within the meaning of the Interpretation Act 1978).”
Perhaps the Minister could clarify what is meant by subordinate legislation, and whether it is the same, or different, from regulation.

Evan Harris: I thought that the hon. Member for Boston and Skegness asked interesting questions. I am particularly interested in the answer to the last one, as I, too, had that written down. Inspections would not be excluded from being contracted out under proposed new section 8C(2), and that leads to the question about whether it is necessary to identify other people who can provide inspections, albeit apparently public bodies.
My purpose in supporting clause 8 is to recognise that in this increasingly complex area of regulation, particularly with the advent of potential stem cell therapies, it is important that the HFEA is able to hand over this aspect of its work and contract it out, under negotiation and with consultation, to the HTA or the MHRA, so that there is a smooth working arrangement. The MHRA, for example, could take the lead and would obviously have to refer back on occasion to the HFEA. From the reading that I have done of some of the complexities around the European directive on cells and tissues for human application, it seems that that sort of thing will be necessary. I hope that the Minister will confirm that.
I understand and hope—again I might be wrong—that one of the other points of this is to ensure that the authority can delegate certain powers to a sub-committee, which might speed up processes. There is concern in the clinical world that it can take a very long time for the authority to make a decision. I think that without that provision, the authority has to meet as a full authority to sign off a number of things, and that potentially refers to the creation of sub-committees or committees of the authority. Again, I would be grateful if the Minister could clarify that.

Mark Simmonds: The hon. Gentleman is absolutely right. Perhaps I may refer him to clause 10, which relates to the power to delegate and establish committees. The purpose of that clause is to speed up the licence process. He is right to highlight the concern of many clinics about the time it takes for the HFEA to make its decisions.

Roger Gale: Order. The hon. Gentleman is right—we shall come on to clause 10 in due course.

Evan Harris: I agree with you, Mr. Gale. The hon. Member for Boston and Skegness is right, and perhaps that answers the point. Clause 10 deals with that concern, not clause 8.

Dawn Primarolo: At present, the 1990 Act does not allow the HFEA to enter into an arrangement with either a public or private body to undertake any of its functions. That means that there is limited flexibility when carrying out some of its functions, which could lead to the duplication of inspections or other aspects of its regulatory work. The new provision in clause 8 introduces more flexibility to the way in which the authority operates. The provisions work together with those in clause 9—we are coming on to that—that enable the HFEA to assist other public bodies. It will help the authority to carry out its functions more effectively and avoid duplication, thus reducing the burden on clinics and others subject to licensing. The provision was thought to be sensible to modernise the regulation and keep certain issues within the Bill, following the removal of proposals to establish the regulatory authority for tissue and embryos.
Proposed new section 8B gives the authority power to make agency arrangements with Government bodies, other public authorities or holders of public office, and provides for that body to exercise the authority’s functions, or for it to provide services to the authority. Such arrangements may include, for example, those with the Human Tissue Authority or the Healthcare Commission to carry out inspections on its behalf. Both those authorities are regulated, transparent and responsible. However, the responsibility for the functions themselves would remain with the HFEA, so that body would still be accountable.
Proposed new section 8C gives the power to make a contract with any person to carry out functions of the authority. However, under the provision, the authority cannot contract out functions related to licensing decisions, the right to enter, the search or seizure of property, or other functions prescribed in an order made by the Secretary of State.
For example, the provision allows a private company to undertake inspections of laboratories on behalf of the authority, and the clause provides that the authority remains in control of its functions and responsible for all acts or omissions under such arrangements. We are seeking to remove duplication with other public authorities when that is sensible, thus reducing the number of inspections and the regulatory burden. Any powers in the area would have to be subordinate to the legislation, and that includes the regulating-making powers. It could also include powers such as making orders. The approach is quite straightforward, and because of the exclusions on specific issues, I hope that hon. Members will accept that this is about using similar inspections and expertise in the public sector and reducing duplication, not the HFEA losing control of its responsibilities or transparency. I hope they will also accept my points about what cannot be contracted out and what will remain absolutely central to the work of the HFEA.

Mark Simmonds: I might have misunderstood what the Minister said. Did she clarify the point about this relating only to other public sector bodies so that no independent or private sector charitable or voluntary organisations will get involved, particularly with regard to inspections? Inspections are not specifically excluded as are, quite rightly, licensing and the other issue with regard to the code of practice. What about the specific point regarding the interim inspections?

Dawn Primarolo: May I help the hon. Gentleman by making an intervention? Proposed new section 8C gives authority to contract with another person to carry out functions and sets out exclusions. In the example I gave, such a function might be undertaking an inspection of a laboratory on its appropriateness, but would not include the other functions: licensing, right of entry, and search or seizure. That would occur in limited circumstances, and that possibly could go beyond a public authority. However, others provisions relate to public authorities.

Mark Simmonds: I am grateful for that clarification, as I understood what the Minister just confirmed: the HFEA is going to be allowed to contract out not just to the public sector, but, in very specifically defined circumstances, to the independent sector, as the Minister explained.

Question put and agreed to.

Clause 8 ordered to stand part of the Bill.

None

Power to assist other public authorities

Question proposed, That the clause stand part of the Bill.

Michael Penning: I will not detain the Committee for long. I find the clause quite interesting because of the ambiguous language in the Bill. It allows the authority to assist other public authorities and then, quite naturally, to charge them should it do so. I am conscious that those bodies could be some of the ones that the authority has already contracted out to that could be charged for the work that the authority does for them. I am particularly concerned about proposed new section 8E(2), which states:
“Assistance provided by the Authority under this section may be provided on such terms, including terms as to payment, as it thinks fit.”
Could we be in a situation in which one department—the authority—is charging another part of Government, but they do not agree and therefore the work cannot be done? The measure is very ambiguous. This is the second time this afternoon that we have seen such terminology—“as it thinks fit”—in the Bill, so will the Minister clarify it?

Dawn Primarolo: The provision is a reciprocal arrangement with proposed new section 8B. New section 8E will permit the HFEA to provide services to other public bodies, such as the Human Tissue Authority or the Healthcare Commission, undertaking inspections in the same premises as the HFEA. They might arrange for the HFEA to cover their inspection in the course of the authority’s inspection regime. The HFEA, not the Healthcare Commission or the Human Tissue Authority, would then carry the cost of undertaking the inspection. The provision gives a mechanism for sharing the benefits of reducing the burden to those who are inspected and the cost to the public authorities performing the inspections.

Michael Penning: I thank the Minister for being so clear. I only wish that this part of the Bill, which is quite long and detailed, had given us a couple more sentences, as the Minister has done. The provision is very simply put: “as it thinks fit”. I do not wish the Minister to disappear soon, but other Ministers will be around to take her place. They will see the provision in the Bill, and the situation is not as clear in the Bill as the Minister has described.

Dawn Primarolo: But the clauses interact together, so if we rewind to the debate on better regulation and the obligations of the HFEA in discharging its duties as a public authority, the same duties apply to the Healthcare Commission or the Human Tissue Authority. Those public bodies would act responsibly and accountably. I think that the hon. Gentleman is concerned that the HFEA would act in a predatory fashion by charging another public authority for the purposes of income generation, following which there would be a dispute.
I do not know why parliamentary draftsmen settle for these phrases, although they are excellent people who do fantastic things and get our legislation into understandable forms, whatever the hue of the Government. I assure the hon. Gentleman that the measure does not provide for some sort of turf war or disagreement on charging, and I hope that he accepts that. It is reasonable to reduce regulation, and when there is a gain to one authority because another authority has undertaken work, there will be a sharing of benefits between the authorities, as well as a clear benefit to the establishment that was inspected, because it will end up with only one inspection, rather than two.

Question put and agreed to.

Clause 9 ordered to stand part of the Bill.

Clause 10

Power to delegate and establish committees

Question proposed, That the clause stand part of the Bill.

Mark Simmonds: Again, I just have a few questions for the Minister. Will she clarify the exact possible workings of clause 10, which deals with contracting out to, and the setting up of, committees? The clause gives the authority the power to delegate and establish committees, and there is concern over the accountability and transparency of the process. Will the Minister tell us her thoughts on which committees the HFEA thinks it might be appropriate to set up? To whom would it delegate and on what terms, and what would be the relationship between the committees and the HFEA?
I also understand that the committees can include people who are not members of the HFEA, thereby potentially linking back to some of our discussions on earlier clauses about the appropriateness, the qualifications and the relevance of some of the people who may serve on the committees. Will the Minister explain exactly why it is necessary for the authority to be able to set up the committees? What has not worked well in the HFEA to date that makes it necessary? Why is it necessary to be able to bring in outside people who are not members of the authority?
I would also like to make sure that clause 10 will not allow the authority to move away from decisions licensed by the senior level in the authority and from responsibility for the code of practice. I understand that the purpose—again, it would be helpful if the Minister confirmed this—is to speed up the decision-making process. There is clearly concern about the time that some licensing decisions take, but it is important to maintain transparency and accountability. Some clinics have serious concerns about licensing being renewed at a purely executive level, not an authority level. A confirmation is needed that the appeal process will remain in place, despite the powers to delegate down, and that it will remain the same structure and fall to the people on the appeal panel, not the people who made the original decisions.
The Minister will also be aware of the context. There has been judicial criticism of the former chief executive. I do not want to go into detail, but it may in part drive some of the concerns. Of course I understand that a process is needed for speeding up decision-making for granting licences, but it would be helpful if she would confirm whether delegation applies to all categories set out in the Bill for which the HFEA has responsibility, which include licensing, variation, suspension and revocation.

Robert Key: The explanatory notes to clause 10 have, I regret to say, managed to confuse me. I should be grateful for clarification on two simple points. If the Minister can convince me, my mind will be at rest. I am not clear whether it is meant that staff will be able to take licensing decisions and develop the code of practice. That is what it seems to say. Can she also point us to the measure in the Bill—if she cannot, could she tell us—what functions will still be able to be exercised only by members of the HFEA?

Dawn Primarolo: At present, the 1990 Act requires HFEA members to be involved in all licensing decisions. As hon. Members have said, there has been comment about whether that is overly restrictive on the speed with which decisions are taken, particularly with regard to what might be considered routine licence applications. Clause 10 provides that the authority can set up committees to which it can delegate any of its functions. It will give the HFEA the flexibility to determine how best to manage its licensing process. That may involve divisions between more routine decisions and decisions that are slightly more challenging or contentious.
The new provisions mean that there will no longer be a specific requirement for a licence committee to be set up, nor will any such committee be required to comprise only HFEA members. Under the new provisions, for instance, the delegation to any committee could include members as well as a member of staff.
Under the 1990 Act, the authority could not delegate any function relating to licensing in that way. The Bill ensures that the HFEA can delegate licensing decisions to staff, ensuring that such decisions can be made quickly and within a framework set by the authority. There will need to be an escalation procedure to ensure that difficult or more contentious decisions are taken with the appropriate authority under these delegated powers. Therefore, we are asking the HFEA to consider how to deal speedily with licence applications.
The provisions are sensible and provide flexibility so that the authority can speed up its decision making and meet requirements of better regulatory practice. That will help the authority respond proportionately to its functions, delegating when appropriate, which should speed up decision making and cut costs. We thought that this provision was sensible to modernise regulation and would be in keeping with the Bill. It was particularly necessary following the removal of the proposal to establish the regulatory authority for tissue and embryos. As we took that part of the regulation out, we needed to have something in this clause instead. The provision should help to speed up the matter, but it does not remove the responsibility of the entire authority for the decisions that are taken. It is a question whether—I am struggling for the words to describe this—there are less complicated decisions that could then be endorsed by the full Committee, but that could be considered more quickly. The question of the appeal process and everything that needs to be in place is there. That is the main requirement. Arrangements are continuing to be reviewed and put in place to ensure that the provision is robust.
I hope that members of the Committee will be reassured that this is a proportionate response to criticism of lack of speed in agreeing licences, particularly when they are straightforward. The provision recognises the full range of expertise in the authority, but none the less makes it clear that decision making has to be speeded up.

Robert Key: I should be grateful if the Minister would be so kind as to write to me in response to one of my points and share the letter with members of the Committee. I asked her what functions could be exercised only by the members and could not be delegated.

Dawn Primarolo: I am happy to do that. The members will still be responsible for all decisions, because there will need to be an endorsement. In that sense, there is no removal of power from the members of the board. As regards providing flexibility to the HFEA, I will be happy to write to all members of the Committee, through you, Mr. Gale, to explain the sort of things that we would want to interact to ensure that there is no loss of accountability, expertise and scrutiny in this area by the regulatory authority that we have put in place.

Mark Simmonds: My hon. Friend the Member for Salisbury has, as always, hit the nail on the head. I am very grateful to the Minister for consenting to his request to circulate a clarification letter to the Committee. I think that there would be concerns if the HFEA was allowed to delegate the totality of functions, including licence suspension or revocation, without retaining control over the key ones. I am grateful to the Minister for giving way and also for agreeing to send us a letter, which we will look at closely.

Dawn Primarolo: I am more than happy to do that. This was a matter that the pre-legislative scrutiny Committee looked at when considering flexibility for the HFEA, although not necessarily in this area. I assure the hon. Members for Boston and Skegness and for Salisbury that the points that they have raised were precisely those that I and my officials, who will remain nameless, focused on. We wanted to ensure that the regulatory authority continued to discharge its statutory duties correctly. I happily undertake to get those details to members of the Committee as quickly as I can.

Question put and agreed to.

Clause 10 ordered to stand part of the Bill.

Roger Gale: For clarification, and in case anyone thinks I have had a brain storm, clause 11 was taken on the Floor of the House.

Clause 12

General conditions of licences

Dawn Primarolo: I beg to move amendment No. 39, in clause 12, page 8, leave out line 31 and insert—
‘(1) Section 12 of the 1990 Act (general conditions of licences under that Act) is amended as follows.
(2) In’.

Roger Gale: With this it will be convenient to discuss Government amendments Nos. 40 to 43, 106, 108 and 115 to 117.

Dawn Primarolo: I was looking for clause 11, Mr. Gale—it has been rather a long afternoon already.
During the passage of the Bill through another place, a debate took place on the use of embryonic stem cells derived under research licences in therapeutic applications. The Government subsequently wrote to all peers involved in that debate setting out how, in the Government’s view, embryonic stem cells derived under an HFEA research licence could be used in therapeutic applications. The amendments are consequential to the Government’s taking that view in another place. They will ensure that research centres deriving embryonic stem cells that are intended for therapeutic use are required to abide by the quality and safety standards set out in the European tissues and cells directive, in relation to stem cells and the embryos from which they are derived.
The directive lays down standards of quality and safety for human tissues and cells intended for human application, including gametes and embryos. The relevant requirements already apply to embryos used in reproductive treatment under the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007. Stem cells derived from embryos are also regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. It is important that those standards are applied also to the embryos used to derive stem cells in human applications in order to ensure the necessary levels of quality and safety of tissues to be used in treatment.
I commend the amendments to the Committee.

Mark Simmonds: I am grateful to the Minister for introducing this batch of amendments. I have one or two queries. I understand the logic of what she said, but there is no mention anywhere else in the Bill of therapeutic applications for humans. Indeed, on the Floor of the House I and the hon. Member for Oxford, West and Abingdon tabled separate amendments and new clauses to allow licence for therapies to take place, but they were rejected by the Minister.
It would be helpful if the Minister were to explain the wording used in the letter that she kindly sent Committee members. How does the phrase
“intended for non-reproductive therapeutic application for humans”
fit in with her view that she will not allow licences for therapies in the Bill? That letter then refers to
“Directives on safety and quality of cells and tissues for human applications”
and “the relevant requirements”. What are the relevant requirements to which the Minister refers? The letter refers euphemistically to “these safeguards”. Will the Minister explain what they are?
After the debates in the other place, I initially thought that the application of the EU directive did not apply to non-medical fertility services. However, the Minister has confirmed today that it does apply to them. Will she clarify that matter? Does it also cover the provision of gametes for such purposes for both non-medical fertility services and non-reproductive therapeutic applications?

Evan Harris: I seek your advice, Mr. Gale. I think that the last two important questions raised by the hon. Member for Boston and Skegness, were clause stand part-type questions, because the deletion of the exception for non-medical fertility services is already in clause 12. We are debating, initially, additional amendments to that. Will you let me know shortly whether you wish me to deal with my questions around non-medical fertility services?
The hon. Member for Boston and Skegness has raised an important issue. I am aware that we cannot really reopen the question of licences for therapy at this stage, but, as he said, the issue involves stem cells intended for non-reproductive therapeutic applications to humans. My question for the Minister is simple. Would that cover non-research applications to humans, or would that always cover research applications for the lifetime of the Bill? If it includes non-research applications, then further questions are raised about whether the Government are right to be confident that any applications of stem cells derived from embryos created under a licence could be created under a licence for research, because there will always be research involved in the process? We cannot reopen that discussion here, and I am not proposing to, but it would be helpful for the Minister to clarify her view. Would those non-reproductive therapeutic applications to humans apply to non-research applications? Does her definition of research apply to clinical trials? That is one understanding—research carried out under a research ethics committee approval, with a clear protocol. Or is research to be read more widely—some would say much more widely?
I will make two more points. It is important, looking at the 1990 Act as amended, that the safeguards apply here. The safeguards referred to include the transfer of money and information and maintaining proper records. The clause is important, therefore, because those are the general conditions of licences.
My second question I cannot remember. I might seek to intervene on the Minister, if it occurs to me.

Roger Gale: Order. I indicated earlier that, in principle, I was perfectly happy to have a stand part debate at the start rather than at the end. For that reason, given that it is often easier to take matters in context, I am perfectly happy to allow the debate now. If the hon. Gentleman wishes to add to his remarks, please feel free to do so.

Evan Harris: On the issue of non-medical fertility services, I think that what the Government are doing in the clause is removing the exception for such services from the provisions. The tissue directive and indeed the European Communities Act 1972 section 2 process did not permit the Government to apply the licence conditions that we see in the clause to non-medical fertility services.
What are non-medical fertility services? They are defined in section 2 of the Act as
“any services that are provided in the course of a business, for the purpose of assisting women to carry children, but are not medical, surgical or obstetric services.”
It would be useful for the Committee to know what are not the “medical”, which I guess is using drugs, “surgical or obstetric”, which speak for themselves, “services” that will be covered by the general licence conditions, which are extensive. How have we survived for so long under the 1990 Act with non-medical fertility services—my reading of the measure might not be correct—apparently not subject to the licence conditions? To put it another way, will the Minister assure us that this is not a discretionary regulation and, even if it is, that it is not over-regulation of services that would not necessarily require regulation by the HFEA? There is a general trend that as soon as an authority is regulating things, it wants to continue regulating them and identify new things to regulate. It is sometimes the job of Parliament to retreat from that trend. [Interruption.] The ironic laughter of the hon. Member for Norwich, North reminds me that a number of Select Committee reports, particularly the report that came out under his chairmanship in 2005, argued that it was time that the HFEA did not regulate basic fertility treatment because it is now pretty standard. It is useful to collect information, but is it right that licensable matters are subject to all such regulations, while, for example, surgery to remove the blocking of fallopian tubes to treat infertility continue to be completely unregulated by the HFEA? Such treatment is currently subject to all the other regulation that currently binds doctors. That is a wider issue, but I have been provoked by the inclusion of non-medical fertility services in the scope of the licence conditions in the clause.

Dawn Primarolo: Can I reassure the hon. Member for Oxford, West and Abingdon that he should not be provoked by the use of the term
“non-medical fertility services”?
He asked me what they might be: essentially, the measure is about internet sperm delivery services—he may have mentioned those. They have to be described as “non-medical” in case any attempt is made to deliver services other than via the internet, which currently happens, apparently.—[Interruption.] Perhaps I should have used a different phrase.
Moving on, I should explain why the amendments are necessary, which will answer the point made by the hon. Member for Boston and Skegness. The quality and safety standards that are set out in the EU directive are aimed at preventing the transmission of disease from donor to recipient of tissues or cells. Two separate points were made and I do not want to lose the distinction. The EU directive requires that provision is based on the safety and quality of services, and that consent is obtained. That is the set of issues to which the amendments relate.
The second set of issues relate to therapeutic services. The Government believe that the measure applies to research only. Our view is that, under a research licence, an embryo can be used to derive stem cells for human application as long as it can be shown to be part of a project of research. The amendments would introduce a requirement to comply with the directive that is aimed specifically at the limited area of quality and safety, as I described. Two separate issues were conflated by my use of the word “therapeutic” in my earlier remarks. However, the issues are not connected. The amendments relate specifically to the directive arrangements.

Evan Harris: I know what the Minister says, but it shows that the provision of stem cells for therapeutic application cannot be said to be irrelevant to the HFEA or to the Bill. It could be argued that it is a matter for the Human Tissue Act 2004 or the Medicines and Healthcare products Regulatory Agency; that once the cells are used, the embryo is long gone, so it is not a matter for the Bill or HFEA licences. I am keen not to provoke the Minister because we are nearing the end of the sitting, but does she recognise that, even as far as this relatively minor provision goes, when stem cells derived from embryos—not embryos—are put into humans, the licence conditions for the storage, use and creation of the embryo are relevant to the end use, at least in principle? That goes to the question, to which we might return, whether there needs to be greater specificity in other aspects of the licence arrangements for such end uses.

Dawn Primarolo: Was that an intervention, Mr. Gale?

Roger Gale: Yes, but it was a very long intervention.

Dawn Primarolo: Yes, and I listened very carefully to it. The Government have not said that the provision of stem cells for therapeutic application is irrelevant to the HFEA. The issue, which we discussed on the Floor of the House, is whether therapy licences are necessary. It is a separate issue. I can see the tenuous link that the hon. Gentleman is trying to make, which is why I was careful to anchor my comments by saying that we are talking about research for therapeutic services, not the therapies themselves. We had a debate on that on the Floor of the House, as I said. I have concluded my remarks on that and I hope that they were helpful to the Committee.

Amendment agreed to.

Amendment made: No. 40, in clause 12, page 8, line 37, at end insert—
‘(3) In subsection (2)—
(a) omit the “and” at the end of paragraph (a), and
(b) at the end of paragraph (b) insert “, and
(c) every licence under paragraph 3 of that Schedule, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application.”.’.—[Dawn Primarolo.]

Clause 12, as amended, ordered to stand part of the Bill.

Further consideration adjourned.—[Steve McCabe.]

Adjourned accordingly at two minutes to six o’clock till Thursday 5 June at Nine o’clock.